Kornimate/medical-research-clean huggingface dataset:
effect of a vitamin d analogue vs placebo on p-nt-probnp in patients with type 1 dm and diabetic nephropathy

Conditions: Cardiovascular Disease; Diabetic Nephropathy

Summary: the primary objective is to assess the impact of three months of treatment with an active vitamin d analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in type 1 diabetic patients with diabetic kidney disease. the hypothesis is that active vitamin d analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.


Eligibility criteria:
inclusion criteria: * 18-75 years of age * type 1 diabetes mellitus * diabetic nephropathy (defined by persistent albuminuria, \> 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease * chronic kidney disease stage 3 and 4 * s-parathyroid hormone (s-pth)\> 35pg/ml * stabile raas-blocking and diuretic treatment exclusion criteria: * other kidney disease than diabetic nephropathy * myocardial infarction within the last three months prior to visit 1 * coronary artery revascularization within the last three months prior to visit 1 * transitional cerebral ischemia (tci) or apoplexia within the last three months prior to visit 1 * cardiac failure (nyha class iii or iv) * kidney failure (gfr \<15ml/min), dialysis, kidney transplantation) * liver disease with serum alanine aminotransferase (alt\>3 x the normal value * alcohol/drug abuse * hypercalcemia (serum ionized calcium \>1.35 mmol /l) * medication with phosphate and/or vitamin d-containing medications, which can not be paused during the study * clinical signs of vitamin d toxicity * pregnant or nursing women * fertile women not using chemical or mechanical (iud) contraceptive methods * current disulfiram treatment * allergy to the study drug * patient unable to understand the informed consent * any other condition or therapy which, in the opinion of the investigator, makes the patient not suited for participation.

Keywords: cardiovascular disease and mortality plasma ntprobnp uaer
platelet function analysis in head trauma: asa/plavix

Conditions: Head Injury Trauma Blunt

Summary: the investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

the platelet function analyzer verifynow® p2y12 uses adp as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. verifynow® aspirin assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. our research question for this study is as follows: does the administration of desmopressin (ddavp) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by aspirin and/or plavix? the investigators hypothesize that with the administration of platelets and/or ddavp that there is a reversal of the inhibition.

Eligibility criteria:
inclusion criteria: 1. age \> 18yrs 2. must be a trauma patient with blunt head trauma. 3. must be on aspirin and/or plavix 4. subject or legally authorized representative (lar) (per heath and safety code, sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (if this criterion is not met the initial blood draw must be destroyed and not run for study results). exclusion criteria: 1. hemoglobin ≤ 10 gm/dl 2. platelet count ≤ 150 k/mcl 3. pregnant females 4. subjects on warfarin, heparin or enoxaparin
trial of methyl aminolevulinate plus aktilite in facial photodamage

Conditions: Skin Aging

Summary: the aim of the study is to determine the efficacy of mal + aktilite versus placebo + aktilite in facial photodamage in a randomized double blind trial.

it has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (ak). the majority of photorejuvenation or photodamaged published studies have used 5-amino-levulinic acid (5-ala) as a photosensitizer, and either a blue light or an intense pulsed light source with a 70%-95% global facial skin improvement. the molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested. methyl aminolevulinate ( mal) is another marketed photosensitizer mainly utilized in europe. lipophilicity, higher penetration depth and tumor selectivity has been advocated for mal compared to 5-ala. however, its effect in photodamaged skin has not been well documented. the aim of the study is to determine the efficacy of mal + aktilite (pdt) in facial photodamage. study type: interventional study design: randomized, double-blind, placebo-controlled trial. official title: a randomized, double-blind, placebo-controlled trial of methyl aminolevulinate + aktilite in patients with facial photodamage.

Eligibility criteria:
inclusion criteria: * female subjects older than 35 years of age and less than 75 years of age * subjects with a photodamage grade of 2 or 3 according to a modified dover´s global photodamage scale * subjects willing to participate according to protocol requirements. * patients with signed informed consent * patients with no exclusion criteria exclusion criteria: * pregnant or nursing females. * subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization. * any active infectious skin disorder ( herpes simplex, molluscum contagiosum, facial warts ) * subjects with less than 6 months of previous rejuvenation interfering treatments * subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

Keywords: skin aging rejuvenation photodynamic therapy methyl aminolevulinate
the use of vsl#3 in irritable bowel syndrome in children

Conditions: Irritable Bowel Syndrome

Summary: the goal of this study is to determine whether the oral administration of the probiotic vsl#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.

determine the safety and efficacy of different doses of vsl#3 in the treatment of children with irritable bowel syndrome: children will be recruited from the pediatric gastroenterology clinic at the children's medical center in dayton, ohio. eighty four children will be enrolled in this controlled, double-blinded, randomized study. all children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

Eligibility criteria:
inclusion criteria: * all children should fulfill rome ll criteria for ibs. * organic disease has been excluded. * age 13-18 years. * have active symptoms for at least 2 weeks prior to randomization. a minimum of 4.0 on the 7-point likert scale for the two weeks prior to randomization on the gsrs-ibs composite pain score will be required. * diarrhea predominant ibs: diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools. exclusion criteria: * children not fulfilling the inclusion criteria. * children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization. * children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization. * children receiving other medication known to cause abdominal pain. * children diagnosed with any of the following gi disorders: ibd (crohn's disease or uc), celiac disease, gastroparesis, abdominal adhesions, gastrointestinal perforation, gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis. * children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment). * children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism. * children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease. * children with a history of malignancy. * pregnancy. * children with history of allergy to maize or probiotics.
finnish venous ulcer study (finnulcer study)

Conditions: Venous Leg Ulcer

Summary: this multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.

to evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. the scheduled treatment group represents the current standard of care. the primary outcome of this study is the time to ulcer healing. in addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s). class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. the follow-up period for the primary outcome is one year. for this study, based on oulu university hospital's retrospective data (partly published in pihlaja et al 2020) of venous ulcer healing the investigators assumed hazard ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group. assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).

Eligibility criteria:
inclusion criteria: * patient informed consent * venous ulcer, aged from one month to one year * duplex ultrasonography verified (vein reflux greater than \>0.5 second) superficial venous insufficiency * sufficient arterial circulation (at least on criterion met: palpable distal pulses / ankle-brachial index \> 0,8 / toe pressure \>60mmhg) exclusion criteria: * leg ulcers other than venous etiology * ulcers requiring operation theater revision * patent foramen ovale * several times recurrent (over 3 recurrences) venous ulcer * body mass index over 40 * pregnancy

Keywords: venous leg ulcer foam sclerotherapy endothermal ablation sub-ulcer foam sclerotherapy
outcome after selective dorsal rhizothomy concerning life quality, cerebral imaging and cognition

Conditions: Cerebral Palsy, Spastic

Summary: selektive dorsal rhizotomy (sdr) has been used as treatment option in children suffering from cerebral palsy (cp) for several decades and multiple studies demonstrated its benefits. nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. the evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with cp who underwent sdr at the charité university clinics will clarify these critical points in daily care for patients with cp.

sdr at the charité university clinics. two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral palsy * able to perform most tasks according to study protocols * parents and physician decided to perform sdr exclusion criteria: * not able to perform any tasks according to study protocols * no candidate for sdr
effect of oxygen during percutaneous coronary intervention for pain relief

Conditions: Angina

Summary: nasal oxygen is widely used as pain relief against ischemic pain during percutaneous coronary intervention (pci). however, to our knowledge no randomised clinical trials have tested this. in contrast, oxygen causes coronary artery vasoconstriction in man. furthermore, a recent cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. the investigators therefore wanted to examine if oxygen reduces ischemic pain during pci for stable angina or nstemi.


Eligibility criteria:
inclusion criteria: * stable angina or nst-acs undergoing pci exclusion criteria: * blood oxygen \<95% * cognitive dysfunction * stemi * intubation

Keywords: pci oxygen
act for cp individual patient expanded access ind protocol

Conditions: Cerebral Palsy

Summary: individual patient expanded access protocol for a child with cerebral palsy (cp) who has autologous umbilical cord blood available and who is ineligible to participate in other stem cell studies for children with cp.

this protocol is part of an fda individual patient expanded access ind submitted at the request of the parents of a child with cerebral palsy (cp) who is ineligible to participate in other stem cell studies. for this child, there are no other treatment options.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: autologous cord blood stem cells
the effect of high-intensity laser therapy in patients with chronic shoulder pain

Conditions: Chronic Shoulder Pain

Summary: the aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. the treatment program applied was as followed; the control group (n = 25): conventional physiotherapy and study group (n = 25): conventional physiotherapy and high-intensity laser therapy (hilt). upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'the disabilities of the arm, shoulder and hand (dash)'.

the aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. the treatment program applied was as followed; the control group (n = 25): conventional physiotherapy and study group (n = 25): conventional physiotherapy and high-intensity laser therapy (hilt). upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'the disabilities of the arm, shoulder and hand (dash)'.

Eligibility criteria:
inclusion criteria: * volunteered to participate in the study, * aged 18-75 years * being diagnosed with chronic shoulder pain exclusion criteria: * not having sufficient cooperation to follow exercises, * having any communication problems or psychiatric problems, * having any cardiac or orthopedic discomfort that may prevent the application of evaluation methods.
rheox registry study in europe

Conditions: Chronic Bronchitis; COPD

Summary: post-market clinical study (registry study) to collect post-market safety and clinical utility data in european patients with chronic bronchitis treated with rheox.

rheox is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. the energy is delivered via a proprietary catheter through the bronchoscope. two sessions of treatment will be delivered one month apart. the right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. the bronchoscopy will be delivered during general anaesthesia. it is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies. subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.

Eligibility criteria:
inclusion criteria: * patient has moderate to severe chronic bronchitis exclusion criteria: * patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device. * patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type ii second or third degree av block. * patient has airway stent(s), valves, coils, or other lung implant/prosthesis.
comparing ankle fusion to ankle replacement

Conditions: End-stage Ankle Arthritis (ESAA); Osteoarthritis (OA)

Summary: end-stage ankle arthritis (esaa) is a debilitating condition associated with severe pain, dysfunction, and reduced quality of life. many patients with esaa have difficulty walking for even 100 feet or up a single flight of stairs. patients seeking surgery for esaa have two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty (i.e., ankle replacement). few studies have directly compared the effectiveness of these two procedures, and no randomized controlled trials (rcts) have been performed. the investigators will compare the following in subjects undergoing ankle arthrodesis and ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. 1. overall physical function and ankle specific function 2. ankle pain intensity and interference with activities 3. activity levels 4. overall general health 5. post-surgical complication rates the investigators will also identify prognostic factors that are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction.

from study inception until march 2014, the investigators conducted a multi-site randomized controlled trial (rct) comparing the effectiveness of ankle arthrodesis and ankle arthroplasty over a 2-year follow-up period. the study used a modified comprehensive cohort design. subjects unwilling to randomize to surgery could still participate in the study by entering into the preference cohort and select surgery in consultation with their surgeon. by march 2014, no subjects had entered into the randomized cohort. the data and safety monitoring board (dsmb) recommended stopping recruitment in the randomized arm of the study since no subjects were willing to randomize to surgery. all patients were enrolled in the preference cohort and selected arthrodesis or arthroplasty. despite the change in study design, the objectives remain unchanged.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ankle arthritis 2. failed conservative care and deemed a surgical candidate 3. adult patients between 21 and 89 years of age 4. ambulatory but whose primary impediment to pain-free ambulation is ankle arthritis exclusion criteria: 1. recent surgical, neurological, metabolic, or lower limb musculoskeletal problem that might impair the ambulation measures in the study such as severe knee or hip osteoarthritis 2. complicated procedures requiring multiple corrections 3. inflammatory arthritis with multi-focal disease (i.e. arthritis that affects multiple parts of the body) 4. inadequate cognitive or language function to consent to participate 5. unable or unwilling to participate in clinic follow-ups and/or remote follow-ups for 24 months after surgery 6. unwilling or unable to comply with postoperative management program 7. lack of a telephone number or stable mailing address
study of ag-013736 in patients with 131i-refractory thyroid cancer

Conditions: Thyroid Neoplasms

Summary: the primary purpose is to determine how effective ag-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

additional study details: assess safety and efficacy

Eligibility criteria:
inclusion criteria: * radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer * at least 1 measurable target lesion, as defined by recist exclusion criteria: * thyroid lymphoma * previous treatment with anti-angiogenesis agents * no myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.

Keywords: vegfr inhibitor tyrosine kinase inhibitor anti-angiogenic carcinoma papillary follicular medullary anaplastic